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510(k) Data Aggregation
(123 days)
Mission Creatinine Reagent Kit is for the quantitative determination of creatinine in serum, plasma, or urine on the Beckman Synchron CX® & CX® Delta Systems. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in renal dialysis, and as a calculation basis for measuring other urine analytes.
Creatinine is determined by mixing a sample with the alkaline picric reagent, Creatinine from the sample combines with the reagent to produce a red-colored complex. Absorbance readings are taken at both 520 nm and 560 nm at 25.6 seconds after sample addition. The differential absorbance is a direct measure of the concentration of Creatinine in the sample.
Here's a breakdown of the acceptance criteria and study information based on the provided text, structured to address your specific questions:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device and the specified guidelines (NCCLS EP5-A and EP9-A2). The "acceptance" is demonstrated by the Mission Creatinine Reagent exhibiting "similar" performance characteristics to the Beckman Creatinine Reagent.
| Performance Metric | Acceptance Criteria (Implied/Compared) | Reported Device Performance (Mission Reagent) |
|---|---|---|
| Precision | Meeting NCCLS Guideline EP5-A standards (typical ranges for clinical assays) and showing comparable precision to the predicate device. | Serum Control 1 (1.6 mg/dL): |
| Swr (within run sd) = 0.07 mg/dL (4.4% CV) | ||
| ST (Total sd) = 0.14 mg/dL (8.4% CV) | ||
| Serum Control 2 (6.9 mg/dL): | ||
| Swr (within run sd) = 0.10 mg/dL (1.5% CV) | ||
| ST (Total sd) = 0.62 mg/dL (8.9% CV) | ||
| Urine Control 1 (89 mg/dL): | ||
| Swr (within run sd) = 0.7 mg/dL (0.8% CV) | ||
| ST (Total sd) = 10.9 mg/dL (12.3% CV) | ||
| Urine Control 2 (217 mg/dL): | ||
| Swr (within run sd) = 2.2 mg/dL (1.0% CV) | ||
| ST (Total sd) = 9.5 mg/dL (4.4% CV) | ||
| Method Comparison (Serum) | Good correlation with the predicate device (Beckman Reagent) as per NCCLS Guideline EP9-A2, with a strong linear relationship (r² close to 1) and small systematic/proportional bias. | Mission = 1.000 x Beckman + 0.003 |
| Range = 0.2 to 11.8 mg/dL | ||
| r² = 0.998 | ||
| df = 70 | ||
| n = 71 | ||
| S(yx) = 0.13 mg/dL | ||
| Method Comparison (Urine) | Good correlation with the predicate device (Beckman Reagent) as per NCCLS Guideline EP9-A2, with a strong linear relationship (r² close to 1) and small systematic/proportional bias. | Mission = 0.988 x Beckman + 0.634 |
| Range = 10 to 400 mg/dL | ||
| r² = 0.999 | ||
| df = 44 | ||
| n = 45 | ||
| S(yx) = 3.17 mg/dL | ||
| Recovery to Expected Values (Serum) | Similar recovery to the predicate device, ideally within a clinically acceptable range (e.g., 90-110%). | Range of average % Recovery: 85.7 - 105.3 |
| Overall Mean Recovery: 98.5 | ||
| Comparable to Beckman's 93.4 - 114.3 range and 104.2 mean | ||
| Recovery to Expected Values (Urine) | Similar recovery to the predicate device, ideally within a clinically acceptable range. | Range of average % Recovery: 87 - 102.1 |
| Overall Mean Recovery: 96 | ||
| Comparable to Beckman's 83 - 102.9 range and 96.2 mean | ||
| Functional Sensitivity | Lowest level where %CV is less than 20% should be adequate for clinical use and comparable to the predicate. | Lowest level with %CV |
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(54 days)
The creatinine reagents: Alkaline Diluent(R1), product No. CA105-01 and Piccio Acid ed the second of a CA105-02-are intended for Invitro Diagnostic use in the automated, The creatinine reagents: Alkaline Diluent(R1), product No. CH10507 use in the automated, (R2), product No. CA105-02 are intended for Invitro Diagnosic use in the automated, (R2), product No. CA105-02 are intended for Interest of the
CREATININE Reagent
The provided document is a 510(k) clearance letter for a medical device called "CREATININE Reagent". It outlines the FDA's decision to clear the device for marketing based on substantial equivalence to a predicate device. However, the document does not contain any information regarding the acceptance criteria, study details, performance data, or ground truth establishment for the CREATININE Reagent device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document is a regulatory approval letter, not a scientific study report.
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(82 days)
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